Not Yet RecruitingNot Applicable

Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain

30 participantsStarted 2025-05

Plain-language summary

This is a single-center, randomized, open-label, pilot study in adult subjects with chronic sacroiliac joint (SIJ) pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects at least 18 years of age at Screening
✓. Primary complaint of buttock or axial low-back below L5 suggestive of unilateral or bilateral SIJ-mediated back pain
✓. Positive SIJ provocative testing (at least two tests must be positive)
✓. Thigh thrust test
✓. Distraction test
✓. Gaenslen's test
✓. Compression test
✓. Sacral thrust test

Exclusion criteria

✕. Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine
✕. Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:
✕. Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)
✕. Infection
✕. Tumor
✕. Traumatic fracture
✕. Systemic inflammatory spondyloarthropathy
✕. Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)

What they're measuring

Safety and Clinical Effectiveness of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA)

Timeframe: 0-12 months

Trial details

NCT IDNCT06935539

SponsorMedical Pain Management Services, PLLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Kasandra Cliff, MSN, RN

518-371-6772 khopkins@northwayspc.com

View on ClinicalTrials.gov More Chronic Sacroiliac Joint Pain trials